Oral Berotralstat Expanded Access Program

BioCryst

Status

Conditions: HAE; Prophylaxis; Hereditary Angioedema

Treatments: Drug: Berotralstat

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04428632

BCX7353-308

Details and patient eligibility

About

This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.

Full description

Physicians may request access to berotralstat for eligible participants with unmet medical need

Physicians can send email inquiries to [e-mail] or call 1-888-225-8677

Patients who may be interested should contact their physician about participation

Berotralstat (BCX7353) will be available through this expanded access program until it is commercially available

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for participation in this program:

1. At least 12 years of age
2. Able to provide written, informed consent or assent
3. Patients with a clinical diagnosis of HAE Type I or II who, in the opinion of their treating physician, are expected to benefit from an oral treatment for the prevention of angioedema attacks, and who are not eligible or able to access a berotralstat clinical trial
4. Females must use acceptable effective contraception

Exclusion Criteria

Patients must meet none of the below exclusion criteria to be eligible for participation in this program:

1. Pregnancy or breast-feeding
2. Any clinically significant medical condition or medical history that, in the opinion of the treating physician, would interfere with the patient's safety
3. Current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)